The Food and Drug Administration failed to heed warning signs that there were mounting concerns with one of the nation's largest infant formula makers, as a series of babies' severe illnesses and whistleblower complaints began to accumulate ahead of a critical shortage in 2022, the agency's watchdog has found. Eventually Abbott, that formula maker, would institute a massive recall and shutdown of their plant - but by that time, the FDA's lack of communication or sufficient oversight systems had hampered their response, according to the findings of an investigation by the inspector general of the Department of Health and Human Services. The IG's findings, scheduled to be released Thursday, were revealed in an exclusive interview with ABC News.
The audit, announced in June 2022, assessed how the agency responsible for the safety of the nation's food and medication supply responded to complaints of infants' illnesses after eating formula from industry titan Abbott's plant in Michigan- and strains of the same rare but deadly bacteria had been detected inside that facility. "If FDA had adequate policies and procedures, it could have identified underlying problems at the Abbott facility and required Abbott to correct them," the audit concluded. While the agency "took some action" on facility inspections and follow-up, "more could have been done leading up to" Abbott's formula recall two years ago.
Carla Lewis, the assistant inspector general who led the investigation, told ABC News.
